Phase 2
N=24
Doxorubicin-eluting LC Bead M1 for Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02007954 ↗Enrolled (actual)
24
Serious AEs
16.7%
Results posted
Aug 2017
Primary outcome: Primary: Success of DEBDOX-M1 Procedure as a Measure of Feasibility — 100 percentage of successful treatments
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DEBDOX (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of DEBDOX-M1 Procedure as a Measure of Feasibility |
100 | — |
| PRIMARY Collection of Adverse Events Related to Study Device as a Measure of Safety |
6; 4; 2; 2; 1; 1 | — |
| SECONDARY Efficacy - Tumor Response by EASL |
5; 5; 10; 3; 10; 20 | — |
| SECONDARY Efficacy - Tumor Response by qEASL |
5; 4; 13; 1; 9; 22 | — |
| SECONDARY Efficacy - Tumor Response by mRECIST |
5; 5; 11; 2; 10; 21 | — |
| SECONDARY Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions |
6 | — |
| SECONDARY AFP Tumor Marker Pre- and Post-treatment |
289.7; 145.4 | .01 sig |
Summary
The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with hepatocellular carcinoma (HCC). The beads (LC-Bead M1) will be loaded with doxorubicin (DEBDOX-M1), and used to administer transarterial chemoembolization (TACE) DEBDOX, loaded with doxorubicin, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of doxorubicin into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive the smaller beads (DEBDOX), should it be recommended.
Eligibility Criteria
INCLUSION CRITERIA
- The patient has preserved liver function (Child-Pugh A-B class) without significant liver decompensation.
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
- The patient is age 18 years or older.
- The patient has a life expectancy of > 12 weeks.
- The patient has measurable or evaluable disease that will be directly treated with intrahepatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
- The patient has adequate hematologic function as defined by the following criteria:
- An absolute neutrophil count (ANC) ≥ 1500/micro L,
- Hemoglobin ≥ 9.5 g/dL, and a
- Platelet count ≥ 50,000/micro L.
- The patient has adequate hepatic function, as defined by the following criteria:
- Total bilirubin 70% of the liver volume.
- The patient has clinically significant ascites. Trace ascites on imaging is acceptable.
- Marco-shunting noted on the hepatic angiogram.
- The patient has untreatable bleeding diathesis.
- The patient has complete main portal vein thrombosis with reversal of flow.
- The patient has a left ventricle ejection fraction of less than 45%.
- The patient has evidence of clinically significant peripheral vascular disease.
- The patient has clinically significant or symptomatic extrahepatic disease, for example, an uncontrolled inter-current illness including, but not limited to:
- Ongoing or active infection requiring parenteral antibiotics
- Symptomatic congestive heart failure (class II to IV of the New York Heart Association classification for heart disease)
- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- Uncontrolled hypertension (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg, found on 2 consecutive measurements separated by a 1-week period despite adequate medical support)
- Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [NCI-CTCAE Grade 3] or asymptomatic sustained ventricular tachycardia)
- Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements
- There is evidence of substance abuse or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
- The patient is pregnant or breast-feeding.
- The patient is allergic to contrast media that cannot be readily prevented with premedication or managed.
- The patient has extra-hepatic, metastatic, and symptomatic HCC.
Data sourced from ClinicalTrials.gov (NCT02007954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.